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GMP-Creative Biolabs, One-stop, Full cGMP Service, Fasten Your Process to Cinical and Market

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USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-871-5806
Fax: 1-631-207-8356
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Viral Removal


Creative Biolabs provides fully cGMP-compliant Viral Clearance Services with a wide selection of viral removal or viral inactivation processes, which is indispensable to demonstrate the safety of your cGMP manufacturing /cleaning processes. For each project, Creative Biolabs assembles a strong team of Ph.D scientists with more than 20 years of experience, to optimize the design and performance of viral clearance processes using a customized approach and deliver the most suitable viral clearance service according to your budget, timeline, and specific requirements.

Viral Clearance Services

Service features

• Design of viral clearance studies (TSE clearance studies are also available)
• Establishment and verification of the process for viral clearance
• Multiple solutions to viral clearance
• Fully qualified facilities and instrumentation
• International regulatory support

Viral clearance testing is mandatory for investigational new drug (IND) submission and is a critical part of the biologic manufacturing process. Creative Biolabs provides viral clearance service compatible to ICH Q5A and other European, US and WHO regulatory guidelines.

Our viral clearance service on a diverse array of cGMP biopharmaceutical products including:

Monoclonal antibodies

Recombinant proteins

Glycoproteins

Blood-derived products

Cell therapy products

Vaccines

Animal-derived products

Medical devices

Methods of Viral Clearance Process

Viral Removal:

• Ethanol Precipitation
• Multiple Chromatography Systems
• Virus Removal Filtration

Viral Inactivation:

• Low or High pH
• Solvent/Detergent
• Chemical Treatment
• UV Treatment
• High Temperature Short Time(HTST) Treatment
• Pasteurization

To discuss your Viral Removal demands or to request a proposal, please contact us by